BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR REAGENT

    MDR report key: 2297139 · Received October 14, 2011

    Report

    Report Number
    2050012-2011-06302
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT 70% OF THE RHEUMATOID FACTORS RESULTS GENERATED ON THE IMAGE IMMUNOCHEMISTRY SYSTEM RECOVERED BETWEEN 20 AND 30 IU/ML. CUSTOMER REPORTED THAT VERY FEW RESULTS GENERATED WERE LESS THAN 20 IU/ML. CUSTOMER REPORTED THAT OTHER CHEMISTRIES HAVE NO ISSUES. ACCORDING TO THE CUSTOMER, THE PHYSICIANS QUESTIONED THE RESULTS. THE PHYSICIANS COMPLAINED TO THE CUSTOMER THAT THERE CANNOT BE SO MANY PATIENT RESULTS BETWEEN 20 AND 30 IU/ML, THE RHEUMATOID FACTOR IS EITHER NEGATIVE (BELOW 20 IU/ML) OR SIGNIFICANTLY RAISED. CUSTOMER REPORTED THAT QUALITY CONTROL WAS RECOVERING WITHIN RANGE. CUSTOMER REPORTED THAT WHEN THE RHEUMATOID FACTOR REAGENT WITH LOT M012376 WAS REPLACED WITH ANOTHER LOT, THE ISSUE WAS RESOLVED. CUSTOMER REPORTED THAT THEY DO NOT BELIEVE THE RESULTS HAVE HAD ANY EFFECT ON PATIENT TREATMENT OR DIAGNOSIS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. ROOT CAUSE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. M012376

    Patients

    Seq Age Sex Outcome Treatment
    1